Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT00530712
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2007-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephanie.a.cihlar@medtronic.com', 'phone': '763-398-7932', 'title': 'Stephanie Cihlar', 'organization': 'Medtronic'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent', 'otherNumAtRisk': 287, 'otherNumAffected': 229, 'seriousNumAtRisk': 287, 'seriousNumAffected': 99}], 'otherEvents': [{'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 17}], 'organSystem': 'General disorders'}, {'term': 'Other Bleeding/lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 16}], 'organSystem': 'General disorders'}, {'term': 'Other Cardiac Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 24}], 'organSystem': 'Cardiac disorders'}, {'term': 'Other Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Other Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 15}], 'organSystem': 'Infections and infestations'}, {'term': 'Other Musculoskeletal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 56}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Other Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 65}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Access site complication - Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Access site complication - Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Acute Stent Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Allergic reaction to contrast dye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Allergic reaction to procedure meds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Amputation of treated limb above metatarsal line', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Amputation of treated limb below metatarsal line', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Artery perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'GI bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Other Respiratory Issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Other Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Percutaneous revascularization of target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 64}], 'organSystem': 'General disorders'}, {'term': 'Stent misplacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Stent/Vessel thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numAffected': 15}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'Primary stent patency, as determined by the core laboratory, was defined as PSV ratio \\< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.', 'unitOfMeasure': 'Percentage of participants with data', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)', 'unitOfMeasure': 'Percentage of participants with data', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Single-Stent Primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio \\< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.', 'unitOfMeasure': 'Percentage of participants with data', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Single-Stent Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.', 'unitOfMeasure': 'Percentage of participants with data', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'title': 'Subjects with MAE', 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Amputation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Clinically-driven TLR', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.', 'unitOfMeasure': 'Percentage of particants with data', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stent Fracture Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}]}, {'units': 'Stent Implanted', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}]}, {'units': 'Stent Implanted', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': '2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}, {'units': 'Stent Implanted', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '3 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}, {'units': 'Stent Implanted', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 2 and 3 Years', 'description': 'Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.', 'unitOfMeasure': 'percentage of stents implanted', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Stent Implanted', 'denomUnitsSelected': 'Stent Implanted', 'populationDescription': '263 stents analyzable at 1 year'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Decline in Rutherford Clinical Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with available RCC data'}, {'type': 'SECONDARY', 'title': 'Improvement in Rutherford Clinical Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.', 'unitOfMeasure': 'Percentage of participants with data', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Increase in Ankle-Brachial Index From Baseline to 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI \\< 0.9.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assisted Primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '90.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'Assisted primary patency at 1 year was defined as PSV ratio \\< 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.', 'unitOfMeasure': 'Event free percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '82.6', 'upperLimit': '90.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'Secondary patency was defined as PSV ratio \\< 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.', 'unitOfMeasure': 'Event free percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Absolute Claudication Distance Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.18', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.', 'unitOfMeasure': 'Miles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walking Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '40.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with available WIQ data at 1 year'}, {'type': 'SECONDARY', 'title': 'Duplex Ultrasound ≤ 2.4 Primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex Peripheral Self-Expanding Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '77.9', 'groupId': 'OG000', 'lowerLimit': '72.4', 'upperLimit': '82.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.', 'unitOfMeasure': 'Event free percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System'}], 'periods': [{'title': 'Enrollment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Total Enrolled Subjects', 'groupId': 'FG000', 'numSubjects': '287'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subjects Available at Discharge', 'groupId': 'FG000', 'numSubjects': '287'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '30 Day Follow-up Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects Expected for 30-Day Visit', 'groupId': 'FG000', 'numSubjects': '287'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subjects that Completed 30-Day Follow-up Visit', 'groupId': 'FG000', 'numSubjects': '280'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}, {'title': '6 Month Follow-up Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects Expected for 6-Month Visit', 'groupId': 'FG000', 'numSubjects': '287'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subjects that Completed 6-Month Follow-up Visit', 'groupId': 'FG000', 'numSubjects': '275'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': '12 Month Follow-up Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects Expected for 12 Month Visit', 'groupId': 'FG000', 'numSubjects': '287'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subjects that Completed 12-Month Follow-up Visit', 'groupId': 'FG000', 'numSubjects': '263'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'EverFlex™ Peripheral Self-Expanding Stent System', 'description': 'Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '190', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '244', 'groupId': 'BG000'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2007-09-14', 'resultsFirstSubmitDate': '2014-07-28', 'studyFirstSubmitQcDate': '2007-09-14', 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-28', 'studyFirstPostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Patency', 'timeFrame': '1 Year', 'description': 'Primary stent patency, as determined by the core laboratory, was defined as PSV ratio \\< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.'}, {'measure': 'Major Adverse Events', 'timeFrame': '30 Days', 'description': 'Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)'}], 'secondaryOutcomes': [{'measure': 'Single-Stent Primary Patency', 'timeFrame': '1 Year', 'description': 'Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio \\< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.'}, {'measure': 'Single-Stent Major Adverse Events', 'timeFrame': '30 Days', 'description': 'MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.'}, {'measure': 'Major Adverse Events', 'timeFrame': '1 Year', 'description': 'MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.'}, {'measure': 'Stent Fracture Rate', 'timeFrame': '1, 2 and 3 Years', 'description': 'Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.'}, {'measure': 'Number of Participants With Decline in Rutherford Clinical Category', 'timeFrame': '30 days', 'description': 'Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss.'}, {'measure': 'Improvement in Rutherford Clinical Category', 'timeFrame': '1 year', 'description': 'Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.'}, {'measure': 'Increase in Ankle-Brachial Index From Baseline to 1 Year', 'timeFrame': '1 Year', 'description': 'Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI \\< 0.9.'}, {'measure': 'Assisted Primary Patency', 'timeFrame': '1 Year', 'description': 'Assisted primary patency at 1 year was defined as PSV ratio \\< 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.'}, {'measure': 'Secondary Patency', 'timeFrame': '1 Year', 'description': 'Secondary patency was defined as PSV ratio \\< 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.'}, {'measure': 'Absolute Claudication Distance Improvement', 'timeFrame': '1 Year', 'description': 'Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.'}, {'measure': 'Walking Improvement', 'timeFrame': '1 Year', 'description': 'Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline.'}, {'measure': 'Duplex Ultrasound ≤ 2.4 Primary Patency', 'timeFrame': '1 Year', 'description': 'Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SFA', 'Popliteal', 'Stent', 'EverFlex'], 'conditions': ['Peripheral Vascular Diseases', 'Claudication']}, 'referencesModule': {'references': [{'pmid': '23642924', 'type': 'RESULT', 'citation': 'Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, Scheinert D, Rocha-Singh KJ. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013 Jul;58(1):73-83.e1. doi: 10.1016/j.jvs.2012.12.066. Epub 2013 May 2.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries.\n* Symptomatic femoral-popliteal atherosclerosis.\n* Willing to comply with all follow-up evaluations at the specified times.\n* Provides written informed consent prior to enrollment in the study.\n\nExclusion Criteria:\n\n* Previously implanted stent(s) or stent graft(s) in the target vessel.\n* Planned use of devices other than angioplasty balloons during procedure.\n* Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.\n* Life expectancy of less than 12 months.\n* Symptomatic femoral disease in the opposite limb.'}, 'identificationModule': {'nctId': 'NCT00530712', 'acronym': 'DURABILITY II', 'briefTitle': 'Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Endovascular'}, 'officialTitle': 'The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II', 'orgStudyIdInfo': {'id': 'P-2424'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTA and Stenting with EverFlex device', 'description': 'Qualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System', 'interventionNames': ['Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System']}], 'interventions': [{'name': 'PROTÉGÉ® EverFlex™ Self-Expanding Stent System', 'type': 'DEVICE', 'description': 'Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.', 'armGroupLabels': ['PTA and Stenting with EverFlex device']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jon Matsumura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'Krishna Rocha-Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prairie Heart Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Endovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}